Coenzyme Q10 and tolerability of simvastatin in subjects with a history of statin-induced myalgia

Part 1: Fourty four participants will be enrolled in this randomised, placebo-controlled study. All 44 participants will have been unable to tolerate statin therapy due to myalgia, and will not be taking a full dose of statin at time of enrolment. All 44 participants will be initiated on simvastatin 10 mg/day for one month, then titrated to 20 mg/day for a further month, then titrated to 40 mg/day for a final month. In a randomised fashion, 22 of the participants will receive 200 mg/day coenzyme Q10, and the other twenty two will receive matching placebo. All participants will be free to either discontinue the study, or drop down the simvastatin dose to a tolerated level, if they experience significant myalgia. At the conclusion of the study, any participants experiencing myalgia and shown to be on placebo will be able to discuss coenzyme Q10 co-supplementation with statin therapy with the researchers. At baseline, at the conclusion of each dose-titration step, or immediately after drop-out from the study, coenzyme Q10 concentration of plasma will be determined, creatine kinase and lactate/pyruvate ratio will be measured, and lipid profiles will be assessed. Myalgia will also be assessed at all visits, via completion of a visual analogue scale for myalgia. A baseline sample will be collected for mitochondrial (genetic) variation analysis. Part 2: Forty-four age and sex-matched controls who have been shown to tolerate statin therapy and not experience myalgia will be selected, and samples will be collected and analysed for mitochondrial (genetic) variation. These results will be compared with the results of the mitochondrial variation screening of the 44 patients who have experienced myalgia on statin, in an effort to find a correlation between mitochondrial variation and myalgia. Part 3: Baseline and 3-month coenzyme Q10 concentration of 44 samples from clinic patients who have not experienced myalgia on statin therapy, will be compared with the coenzyme Q10 concentration of the 44 (primary study) patients who have had myalgia. This study will address whether either the baseline coenzyme Q10 concentration, or subsequent changes in coenzyme Q10 correlate with myalgia.